Tag: laboratory-developed tests

Trump administration announces some COVID-19 tests can skip FDA review, providing new opportunities for dubious lab tests

The Trump administration unexpectedly announced that the FDA will no longer regulate some lab tests, including those for COVID-19. In addition to potentially allowing unreliable COVID tests on the market, the decision creates an opening for more bogus CAM tests.

/ August 27, 2020

Experts slam CAM lab tests, call for better regulation

Experts review the evidence and find that common CAM lab tests have "little or no clinical benefit" and are "a potential risk to patient safety." Regulatory reform is urgently needed to protect the public.

/ March 14, 2019

New FDA regulatory role threatens bogus diagnostic tests

The FDA regulates in vitro diagnostic devices (IVDs) as medical devices. IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing. Instead, it...

/ January 15, 2015